IPG-CETIRIZINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CETIRIZINE HYDROCHLORIDE

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

R06AE07

INN (International Name):

CETIRIZINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

CETIRIZINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0122686001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-06-29

Summary of Product characteristics

IPG-CETIRIZINE - Product Monograph
Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IPG-CETIRIZINE
Cetirizine Hydrochloride Tablets
Tablets, 5 mg, 10 mg, Oral
Histamine H
1
Receptor Antagonist
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, ON, K2E 1A2
Date of Initial Authorization:
JUN 06, 2014
Date of Revision:
JAN 24, 2023
Submission Control Number: 267528
IPG-CETIRIZINE - Product Monograph
Page 2 of 34
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
.............................................................................................2
TABLE OF CONTENTS
...............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
...............................................................................................................4
1.1
Pediatrics
...........................................................................................................4
1.2
Geriatrics............................................................................................................4
2
CONTRAINDICATIONS
..................................................................................................4
4
DOSAGE AND ADMINISTRATION
..................................................................................4
4.1
Dosing
Considerations.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment......................................................4
4.4
Administration....................................................................................................5
4.5
Missed Dose
.......................................................................................................5
5
OVERDOSAGE
...............